In an effort to show research sites the advantages of building mutually beneficial relationships with sponsors, Forte launched the “Site Empowerment Series.” With the help of our series contributor, Beth Harper, we provided sites with tools to jumpstart these relationships, including webinars, blog articles and Q&As.
The series proved overwhelmingly successful, revealing the need for sites to develop a more influential presence in the clinical trial process. One webinar participant noted, “The discussion on site empowerment validated my thoughts and gave me the reassurance I needed in order to have those honest conversations with sponsors.”
If there is one thing we want you to take away from our “Site Empowerment Series,” it’s that sites can set the tone for the site-sponsor partnership. In fact, one of the easiest ways to improve site-sponsor relationships is for sites to take control.
How can you take action?
The key to gaining control is active communication with your sponsor. Being transparent with a sponsor about the tools and information you need to be successful can eliminate confusion and strengthen relationships.
Beth’s “Spectrum of Empowerment Techniques” outlines five steps sites can take to influence site-sponsor relationships.
Step 1: Protocol Design/Feasibility
During a traditional feasibility assessment, sites often don’t have the necessary information to conduct an accurate assessment of whether they are the right fit for a study. Because of this, sites may provide estimates that are unrealistic, leading to lost time and effort during the study.
Beth suggests conducting a “reverse feasibility questionnaire” where the site proactively asks the sponsor for the information they need to truly assess the study feasibility. This could include:
- Any “non-negotiable” contract language that could slow negotiations later in the process.
- Key information such as, study budget, electronic data capture (EDC) or case report form (CRF) guidelines to ascertain data requirements and workload.
Reverse feasibility questionnaires will help the sponsor understand why the information is important to your decision and allow both you and the sponsor to quickly walk away from studies that aren’t a good fit or are unfeasible.
To learn more about reverse feasibility questionnaires, read Beth’s articles “Reverse Feasibility Questionnaires – Site Empowerment Q&A” and “Feasibility Empowerment Techniques.”
Step 2: Site Selection
For many, site selection has become a passive process, where the site waits for the sponsor to approve or decline them for the study. This process can take weeks, even months. In some cases, the site may never hear back from the sponsor at all.
Conduct a dynamic conversation with the sponsor from the beginning, where you:
- Discuss the timeline of the site selection decision with the sponsor
- Provide further information that may influence the sponsor’s decision, such as enrollment potential
- Request a final protocol so you can take a closer look in advance
- Conduct a more detailed review of eligibility requirements
Another way to combat idle time is to prepare in advance. Initiatives such as Transcelerate Biopharma have developed the standard site profile, a document describing all of the basics about a site. Standard site profiles limit the amount of redundant data entry you perform when being considered for a trial by allowing you to complete one standardized form. This form keeps your information and responses to common feasibility questions in one place, easing and accelerating feasibility submissions to sponsors and minimizing your site’s lost time and duplicate efforts.
Maintaining a conversation with the sponsor and developing a site profile will help you become more active in the site selection process, giving your site the information and knowledge it needs to prepare for a successful study.
Step 3: Start-Up
A sponsor may not be aware of a site’s start-up process and, if communication is not maintained, the site may not receive all the information and tools it needs to begin the study. Miscommunication can also negatively influence a site’s study budget.
To avoid confusion, provide your sponsor with information about your site’s internal start-up processes and approval timelines and create a list of information you need from them to get started with the study.
Once you have this information, develop a recruitment resource plan, which will be provided by the sponsor with your study budget as justification for the recruitment budget approval.
Taking these steps will show the sponsor that you are organized and confident in your ability to conduct the study, as well as demonstrate your professionalism and preparedness.
To learn more about how an empowered site handles study start-up, read “Study Start-up Empowerment Techniques.”
Step 4: Site Training
Training provided by sponsors can be generic, lacking role-based specificity. This high-level training can often be repetitive and ultimately wastes time. It can also leave the site with a greater number of data queries, findings from monitors and potential protocol deviations.
Provide sponsors with your staff’s certifications of prior training and mastery of GCP requirements to show them that your time is better spent on protocol-specific training.
Make it a priority to become fully informed about the nuances and complexities of the protocol by:
1. Conducting a dry run of the protocol.
During this mock trial, if you find that you are missing information, tools, equipment, etc. create a list to present to the clinical research associate (CRA) or monitor.
2. Proactively share your findings and questions with the CRA before the site initiation visit (SIV).
You can also craft your own initiation visit agenda by organizing information based on which role will need it.
Making sponsors aware of your site’s specific training needs can eliminate unnecessary time spent discussing what you already know and allow you to expedite the implementation process.
To learn more about empowered site training practices, read “Site Training Empowerment Techniques.”
Step 5: Study Execution
Because the monitoring visit agenda and summary of findings are often driven by the CRA, the site may be left waiting for approval. This could potentially halt the enrollment process as the site stops enrolling patients until they have a confident go-ahead from the CRA.
Employ good quality management practices and identify potential issues as they occur. Proactively request monitoring visits for these issues and create a monitoring visit agenda to be sure that each of your concerns are addressed.
After the monitoring visit, create your own summary of findings and don’t wait for the CRA’s direction before addressing them. Again, maintain proactive and transparent communication with the CRA and ensure timely resolution of issues.
To learn more about site empowerment during study execution, read “Study Management Empowerment Techniques.”
Being more empowered can help sites meet sponsor objectives, as well as decrease inefficiencies, redundancies and frustrations along the way. Implementing even one of the actions listed in the “Spectrum of Empowerment Techniques” can improve the functionality of your site’s study and hopefully make you feel more comfortable with your site-sponsor relationship.
Has your site employed any of these techniques? What was the outcome? Let us know in the comment section.
For a more detailed overview of the “Site Empowerment Series,” watch Beth Harper’s on-demand webinar.
You can also view site empowerment in action with these real-world examples: